A new analysis from the Tufts Center for the Study of Drug Development (CSDD) found that an AI clinical monitoring agent can deliver 82 times the return on investment (ROI) in oncology trials.
The report also found that the AI tool can deliver net financial gains as high as $21 million per drug development program, according to a Wednesday release.
Analyzing the digital trial platform Medable’s clinical monitoring agent, the study looked at expected net present value (eNPV), a method for quantifying the financial impact of innovation investments.
It found that the agent showed eNPV gains of about $7.5 million in a phase 2 trial, $11.3 million in a combined phase 2 and 3 development program and $21 million in a phase 3 trial. A clinical monitoring agent automates administrative tasks in clinical research such as risk-scoring, pre-visit summaries and site communications.
Overall, Tufts found an estimated 64 times the ROI in phase 2 trials and 82 times the ROI in phase 3 trials. For direct operating cost savings, the analysis found $4.4 million per phase 2 trial and $5.6 million per phase 3 study.
“To our knowledge, this is the first time that eNPV modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution deployed to support a drug development program,” said Ken Getz, Tufts CSDD executive director, in the release.
Getz noted that the financial value was created by efficiencies such as reductions in the number of on-site visits and travel costs, as well as accelerated enrollment and database lock timelines.
Further analysis found that agentic AI can speed up clinical development by about 18 weeks, helping sponsors move through the regulatory process faster and potentially reach commercialization sooner. These efficiencies included reducing enrollment timelines by about 109 to 119 days, shortening closeout activities, helping companies realize revenue earlier and lowering development costs.
Agentic AI can also provide administrative off-site monitoring task savings of around $600,000 for a phase 2 trial and $1.7 million for a phase 3 study. Clinical research associates can be reallocated to other studies when they have lower administrative burdens. Those savings were not included in the eNPV calculations.
“The potential impact is magnified when applied across a large oncology portfolio,” said Pamela Tenaerts, M.D., Chief Medical Officer at Medable. “For a sponsor with 20 active indications, deploying a clinical monitoring agent across phase 2 and 3 studies could generate as much as $226 million in incremental portfolio eNPV. For a sponsor with 50 active indications, that figure could jump to as much as $565 million. Bottom line? We now have evidence demonstrating sizable value creation of agents in clinical research, helping break longstanding barriers.”
A 2021 Congressional Budget Office report found that estimates of the average cost to develop a new drug range from less than $1 billion to more than $2 billion, including capital costs and spending on drugs that fail to reach the market. One estimate cited by CBO put the development timeline at about 10.5 years, including nearly eight years in clinical trials.
The analysis was based on benchmarked oncology program and clinical trial data from Tufts CSDD, an independent research group on clinical development economics, and contract value data from Medable.